Chapter 4 – Additional Considerations
Additional considerations to keep in mind before submitting your research for review.
4.1 Is there anything else I need to know before I begin?
4.2 Does the location of my research affect the required review process or submission materials?
4.3 What are my responsibilities as a researcher at Ohio State?
4.4 Are there any additional requirements for student researchers or their faculty advisors?
4.1 Is there anything else I need to know before I begin?
Investigators must submit a detailed explanation of the study, or research protocol, which describes recruitment procedures, the consent process, study procedures, data collection, method of analysis, etc., as well as provide the actual materials to be used with research participants (e.g., scripts, advertisements, forms, questionnaires, etc.).
For more information about what to include in a research protocol for IRB review, see Guidelines for Writing a Research Protocol.
Location can play an important role in determining the risk level of the research and method of review. An Ohio State IRB may only approve human subjects research activities at locations for which the Board has an understanding of the local research context and the university has oversight mechanisms in place. In certain situations, Ohio State may serve as the IRB of record for a collaborative research site and/or collaborating external investigator engaged in Ohio State research.
For more information, see HRPP policy Research Performance Sites and Collaborative Off-Site Research.
Ohio State University Performance Sites
Ohio State maintains a list of approved research sites where Ohio State IRBs have both oversight of the personnel involved in research and knowledge of the local research context. The list can be found at Research Performance Sites.
Non-Ohio State University Sites
Use of non-Ohio State facilities (e.g., schools, nursing homes, businesses, etc.) may be requested for research activities. Limited use of outside facilities or involvement of non-Ohio State personnel who do not become “engaged” in the research (i.e., do not perform research activities involving human subjects) are permitted with Ohio State IRB review. However, when the facility or the facility’s personnel at the non-Ohio State site becomes engaged in the research (e.g., by recruiting participants, obtaining informed consent, collecting data, etc.), additional review requirements apply. When applicable, the external site’s IRB may oversee involvement of its personnel in the study. When the non-Ohio State site does not have an IRB or to avoid duplicative IRB reviews, an Ohio State IRB may serve as the “IRB of record” with appropriate agreements in place and knowledge of the local context. In such cases, inter-institutional agreements, investigator agreements, or redesign of the project will be required to perform the research. For more information on engagement, see Engagement of Institutions in Research.
Collaborations – If non-Ohio State sites or personnel are to be engaged in the research, check with ORRP as soon as possible to determine if other agreements, approvals, etc., may be needed. For more information, see HRPP policy Research Performance Sites and Collaborative Off-Site Research.
International studies often require additional safeguards to protect the rights and welfare of research participants. Ohio State investigators wishing to perform research in international locations must consider the language spoken/understood by potential participants, local customs or laws that might influence how the research is carried out, and possible risks due to social or political conditions. Investigators who will be conducting research internationally need to be prepared to gather and submit the Research in International Settings Appendix, which solicits the following information for IRB review:
- Description of where the research will be conducted (including geographic location and specific performance site, where applicable). Note: In some areas, government-issued research visas are required.
- Copy of local IRB or equivalent ethics committee approval, where applicable. Depending on the location, this may take the form of a letter of approval from an applicable IRB, local university department sponsoring the research, institutional oversight committee, or an indigenous council.
- Information about the local research context, including the current economic, cultural, political, or religious conditions of the area that may affect the conduct of the research, and a description of the investigator’s personal experience conducting research (or studying or residing) in the region.
- The language(s) in which consent will be sought from participants and the research will be conducted, as well as whether the investigator is fluent in this language or whether a translator will be required. If a translator will be used, it should be clear what limitations or risks, if any, this might present for participants, as well as how these potential problems will be overcome or minimized.
- Any local exceptions to the required consent process and, if any, how these will be addressed.
- Copies of the translated informed consent documents and study instruments, as applicable.
- Any benefits to the local community that will remain with the community once the research is complete.
- If compensation is being offered, a description of its appropriateness for the setting.
- Procedures for data storage in the local setting and for transfer of data to Ohio State University.
- If the research is federally funded, verification of the Federalwide Assurance for the international performance site.
All Ohio State investigators and key personnel must fulfill the university’s requirement for education in human subjects protection by taking the web-based course licensed by the Collaborative Institutional Training Initiative (CITI). More information about this educational requirement can be found at Training Requirements. Investigators may also be required to meet additional compliance requirements, including conflict of interest (COI) disclosure requirements. COI information can be found at Conflict of Interest.
This title identifies the individual primarily responsible for the oversight and conduct of the study, including all administrative aspects, and the study’s adherence to relevant policies and regulations (institutional, state, and federal). Only one PI can be named for a project submitted to the IRB. The individual responsible for the conduct of the study (PI) must be a salaried, regular faculty member having at least a 50 percent university appointment. According to university policy, persons holding some university non-academic titles may also serve as principal investigators on projects directly related to the missions and responsibilities of their offices. At Ohio State, students may not serve as PIs on their own projects and must name a faculty advisor as PI. The principal investigator title, while a designation of institutional responsibility for the conduct of a study, does not necessarily represent principal authorship on resultant publications, which is a separate consideration agreed upon by members of the research team.
See Qualifications for Service as a Principal Investigator for further explanation of the requirements to serve as a PI at Ohio State.
This title designates an investigator with an integral part in the research. Individuals do not need to meet the qualifications of PI to be named a co-investigator. For example, a master’s or PhD student submitting dissertation or thesis research for IRB approval will be listed as a co-investigator, with the thesis or dissertation chair/advisor listed as the PI. Similarly, an undergraduate working on a senior or honors’ thesis or other research project should be listed as a co-investigator on an IRB submission. Faculty members should be listed as co-investigators when they do not have primary responsibility for the conduct of the study.
This title designates personnel who play a more limited role in the research than a principal or co-investigator(s). Often, key personnel have little or no input on how the study is designed, but serve a critical purpose on the project, e.g., personnel hired to assist in data collection or analysis, or those responsible for the preparation of regulatory documentation.
Student research projects are reviewed in the same way as any other human subjects research conducted by faculty or staff. Student investigators (after consultation with their faculty advisors) who are planning to conduct a research project involving human subjects must obtain either IRB approval or exemption prior to initiating any research activity/study procedures intended to produce generalizable knowledge. Undergraduate honors’ research, master’s theses, and doctoral dissertations are normally considered to produce generalizable knowledge. “Retroactive” IRB approval or exemption (e.g., for pilot data) is not permitted under federal regulations and university policy. Failure to seek approval for research before beginning may invalidate the study and/or result in noncompliance findings by the IRB.
Ohio State University policy specifies that a student may not be a PI for human subjects research projects, as explained above. However, student co-investigators, under the guidance of faculty advisors, are responsible for:
- Completing the required human subjects education requirements
- Ensuring that the description of the research is accurate and complete prior to submitting to the IRB
- Obtaining IRB approval prior to initiation of the research
- Informing the IRB of all changes or additions to the previously approved study
- Submitting all required progress reports to the IRB
- Reporting to the IRB all unanticipated problems involving risks to subjects or others.
Faculty Advisor Responsibilities
It is the responsibility of faculty advisors to help students determine when a project must be reviewed by the IRB and to guide students through the IRB submission process. When classroom research activities are designed or have the potential to be used by students beyond the classroom, it is the responsibility of faculty advisors to assist students in obtaining IRB approval or exemption prior to the initiation of any project involving human subjects. The faculty advisor ensures that student research projects are conducted according to federal requirements, Ohio State policy, and the ethical standards of the relevant discipline. Faculty advisors must also fulfill the human subjects education requirements when serving as PIs on student projects.
Faculty advisors who supervise student researchers are responsible for the protection of human subjects and are required to:
- Be familiar and discuss with students the ethical and regulatory requirements of human subjects research
- Determine whether projects require IRB review and assist students during the submission process
- Monitor student projects, giving special attention to maintaining participant protections (including privacy, confidentiality, and informed consent), minimizing risk, and ensuring voluntary participation and withdrawal
- Assure that ongoing IRB reporting requirements (e.g., unanticipated problems, continuing reviews) are met in a timely manner
- Oversee submission of the final study report to the IRB when the research is completed.